Drug Closure Systems: Child-Resistant, Senior-Friendly Testing

When the Consumer Product Safety Commission (CPSC) revised its protocol requiring that drug packages be senior friendly as well as child resistant, package designers were faced with a challenge.

Since children between the ages of 18 to 24 months are most likely to ingest poisons, the Poison Prevention Packaging Act mandates the use of child-resistant packaging to protect children under the age of 5. The protocol requires children between the ages of 42 and 51 months be tested sequentially in panels of 50, up to 200 children.

The children are given empty bottles with closures and told to try to open them. They are then given a demonstration on opening packages and told they can use their teeth. They are given a total of 10 minutes to open packages. A minimum of four testers, with each tester conducting no more than 30% of the tests, is used in order to avoid testing bias. A minimum of five test sites are also used, with no more than 20% of the panel from one site. Eighty-five percent of the children must not be able to open the closures before the demonstration, and eighty percent of the children must not be able to open them after the demonstration (based on 200 children).

Seniors are also tested. The testing panel must consist of 100 seniors between the ages of 50 and 70 years old, with 25% of the group between the ages of 50 to 54 years, 25% 55 to 59 years, and 50% 60 to 70 years. Seventy percent of the group must be female. There is a minimum of three testers and a minimum of five sites. The testers first ensure that the seniors can read English, use any necessary eyewear, and understand the test. The seniors are then given 5 minutes to open and re-close the package, and then given 1 minute to do the same with an identical package. Ninety percent of the panel must be able to open and close the package correctly.

Even when effective closures are used, children may still be at risk of poisoning. If the consumer doesn’t replace or close the closure, all the designs in the world won’t keep children safe. The most troublesome challenge for closure designers is making closures so easy to use that consumers won’t even think about leaving the cap off.

Environmental Protection Agency (EPA)
Information about child resistant packaging for pesticides.